FDA WARNING_LETTER - Exclusive Nutrition Products, LLC - May 09, 2022

This FDA Warning Letter addresses Ms. Ward regarding her dietary supplement products, "Thermo Burn" and "5-Alpha." The letter states that introducing or delivering these products into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are adulterated dietary supplements.

The core violation is that "Thermo Burn" contains higenamine HCl and "5-Alpha" contains 5-alpha-hydroxy-laxogenin, neither of which qualify as dietary ingredients under section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)]. Since these substances are not dietary ingredients and are not generally recognized as safe (GRAS) for their intended use in food, nor do they qualify for other exemptions, they are considered unsafe food additives.

Consequently, both products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. The introduction or delivery of adulterated food into interstate commerce is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)].

Ms. Ward is required to notify the FDA in writing within fifteen working days of receipt of the letter, detailing specific steps taken to